JP2020501721A - Drug delivery device with sensing system - Google Patents

Abstract

A drug delivery device comprising a sensing system for determining at least one of dose setting and dose delivery. The sensing system detects a relative rotational position of the first and second members of the device indicating at least one of a dose amount set by operation of the device and a delivered dose amount, and such a relative position. Operable to generate an output correlated to the rotational position. The system includes a wiper coupled to the first member, and a sensing band coupled to the second member for physical contact with the wiper as the second member rotates relative to the first member. And The controller is in electrical communication with the sensing system based on the generated output of the sensing system to determine at least one of the dose set by the operation of the device and the dose delivered.

Description

  The present disclosure relates to drug delivery devices, and more particularly, to sensing systems within drug delivery devices.

  For example, various drug delivery devices, including pen syringes, infusion pumps, and syringes, are commonly used for regular administration of drugs. As the patient's health is at stake, it is important to provide the right amount of medication at these points. In many cases, the inability to accurately deliver the right amount of drug can have serious consequences for the patient.

  Administration of the appropriate amount of drug requires that the actual dosing by the drug delivery device be accurate. The term "dosing" as used herein refers to the two phases of administering a dose, namely, setting the dose and delivering the set dose.

  Drug delivery devices often utilize a mechanical system in which the various members rotate or translate relative to one another. In most cases, these relative movements between the members will be proportional to the amount of dose set and / or delivered by operation of the device. Accordingly, the art seeks to provide a reliable system for accurately measuring the relative movement of members of a drug delivery device to evaluate the set and / or delivered dose. .

  While useful, prior art sensing systems are not without their shortcomings. For example, some sensing systems occupy more space in the delivery device than desired, resulting in more bulky or inconvenient to use delivery devices, or room in smaller devices for the sensing system. This results in a delivery device that has to sacrifice one or more features to have. Some sensing systems use relatively expensive components or may be overly complex, adversely affecting manufacturing costs or potential system reliability.

  Accordingly, it is desirable to provide a drug delivery device with a sensing system that can overcome one or more of these and other disadvantages of the prior art.

  In one aspect, the present disclosure is directed to a first member and a first member about a rotational axis that is proportional to at least one of a dose set and a dose delivered by operation of the drug delivery device. A drug delivery device including a second member rotatable with respect to the first member. A radially projecting wiper is coupled to the first member. An electrically operable sensing band is coupled to the second member. The sensing band is arranged in a curved configuration and is radially disposed with respect to and in contact with the wiper, wherein the relative rotation between the first member and the second member is in progress. The sensing band is operable to generate an output associated with a relative angular position of the wiper along an operating angular length of the sensing band indicating a relative rotational position of the first and second members. The controller electrically communicates with the sensing band to determine at least one of the dose set by the operation of the drug delivery device and the delivered dose based on the output generated by the sensing band. Are combined.

  In another aspect, a drug delivery device includes a first member and a second member rotatable with respect to the first member about an axis of rotation in proportion to an amount of administration set by operation of the drug delivery device. A member, a third member, and a fourth member rotatable relative to the third member about an axis of rotation in proportion to an amount of administration delivered by operation of the drug delivery device. The first wiper is coupled to the first member and projects radially, and the second wiper is coupled to the third member and projects radially. The first electrically operable sensing band is coupled to the second member, and the second electrically operable sensing band is coupled to the fourth member. Each of the first and second sensing bands is arranged in a curved configuration and is radially disposed in contact with and in contact with each of the first and second wipers. During relative rotation between the first and second members, and during relative rotation between the third and fourth members, each of the first and second sensing bands causes the first and second members and the Producing an output associated with corresponding relative angular positions of the first and second wipers along respective operating angular lengths of the first and second sensing bands, indicating a relative rotational position of the third and fourth members. It is operable to A controller is configured to determine the first and second doses set by operation of the drug delivery device based on the output generated by the first and second sensing bands. Are electrically coupled to each of the sensing bands.

  In another aspect, the present disclosure provides a drug delivery device for delivering a drug from a cartridge having a barrel that holds the drug between a movable plunger and an outlet. The device includes a main housing, a cartridge housing for holding a cartridge extending from the main housing, a drive member, and a dose delivery mechanism. The drive member includes a forward end for engaging the movable plunger and has a length extending axially within the main housing. The dose delivery mechanism is for controlling the advancement of the drive member axially forward within the main housing to move the movable plunger to deliver the medicament through the outlet. The dose delivery mechanism includes a first member rotatable relative to the main housing in proportion to at least one of the dose set by the operation of the drug delivery device and the delivered dose. The first member is rotatable relative to the main housing about an axis of rotation extending in an axial direction. A sensing system is provided and is operable to detect a relative rotational position of the first member and the main housing and to generate an output that is correlated to such relative rotational position. The sensing system includes a first wiper and a first sensing band. The first wiper is coupled to the first member and protrudes radially. The first sensing band is coupled to the main housing. The first sensing band is arranged in a curved shape about the axis of rotation and has a first operating angle length. The first sensing band is disposed radially inward or outward of the first wiper such that the first member is in physical contact with the first wiper while rotating with respect to the main housing. . The first sensing band is electrically contacted with a location where the first sensing band is radially operatively engaged along a first operating angle length by physical contact with the first wiper. Including properties. The controller is in electrical communication with the sensing system and determines at least one of the dose set by the operation of the drug delivery device and the delivered dose based on the output of the sensing system.

  The above and other advantages and objects of the present invention, and the manner of achieving them, will become more apparent by referring to the following description of embodiments of the present invention taken in conjunction with the accompanying drawings, in which: And the invention itself will be better understood.

FIG. 2 is a perspective view of the drug delivery device in the form of an injection pen without a cap, prior to attachment of the needle assembly.

FIG. 2 is a partial cross-sectional side view of the injection pen of FIG. 1 after the needle assembly has been mounted and the dosage for delivery has been set.

FIG. 3 is a schematic cross-sectional view taken along line 3-3 of FIG. 2, further illustrating the sensing system.

FIG. 2 is a partial schematic cross-sectional side view of the injection pen of FIG. 1.

FIG. 4 is a perspective view of FIG. 3.

FIG. 3 is an exploded perspective view of a sensing band of the sensing system in an uncurved or straight configuration.

FIG. 7 is a perspective view of the sensing band of FIG. 6 configured in a ring shape.

FIG. 2 is an electronic circuit diagram of a sensing system including a controller microprocessor.

FIG. 7 is a schematic perspective view of another configuration of a sensing band of the sensing system.

FIG. 10 is a partial schematic cross-sectional view similar to FIG. 4 of the sensing system band of FIG. 9 and a suitable wiper installed on the device of FIG.

FIG. 9 is a perspective view of an alternative embodiment of a drug delivery device with a sensing system.

12 is a partial perspective view of the device of FIG. 11 showing the dose delivery detection module removed from the rest of the device.

FIG. 13 is a cross-sectional view of the dose delivery detection module, taken along line 13-13 of FIG. 11, with the remainder of the device shown not in cross-section.

FIG. 9 is a partial perspective view of an alternative embodiment of a drug delivery device with a sensing system with areas for revealing the interior removed.

FIG. 15 is a partial perspective view of an excerpt of a device including the sensing system of FIG. 14.

FIG. 16 is a longitudinal sectional view taken along line 16-16 of FIG. 15.

FIG. 16 is a perspective view similar to FIG. 15 but showing only the sensing band and the core member.

18 is an exploded perspective view of the components shown in FIG.

FIG. 15 is a partially exploded perspective view of a wiper component and a drive sleeve of the drug delivery device with the sensing system of FIG. 14.

FIG. 20 is a partial, perspective view of the wiper component and drive sleeve of FIG. 19;

FIG. 15 is a partially exploded perspective view of a wiper component and a barrel of the drug delivery device with the sensing system of FIG. 14.

FIG. 22 is a partial perspective view of the wiper component and barrel of FIG. 21.

FIG. 9 is a partially exploded, perspective view of a portion of an alternative embodiment of a drug delivery device with a sensing system.

FIG. 24 is a partial perspective view, partially in longitudinal section, of the device portion of FIG. 23 in a housing piece;

FIG. 24 is a schematic view of a sensing band of the sensing system of FIG. 23 in an uncurved or straight configuration.

  Corresponding reference numerals indicate corresponding parts throughout the drawings. Although the drawings represent embodiments of the present invention, the drawings are not necessarily to scale and certain features have been exaggerated or omitted in some of the drawings to better illustrate and explain the present invention. May be.

  Referring now to FIGS. 1-2, there is shown a drug delivery device equipped with a sensing system, which is further described as being used to determine a dose set by operation of the device. Such an amount is determined based on sensing relative rotational movement during dose setting between the components of the drug delivery device, and the sensed movement is correlated as applicable to the set dose amount. I do. In different embodiments, the sensing system may include a dose set and / or a delivered dose set by operation of the device, or, alternatively, a dose set and delivered by operation of the device. It is configured to determine both the amount of administration. One of the advantages of the disclosed embodiments is that it can provide a drug delivery device with a sensing system that can accurately and reliably assess the amount of drug set and / or delivered by the device. It is. Another advantage is that a drug delivery device with a sensing system that requires a limited number of individual components can be provided. Yet another advantage is that a drug delivery device with a sensing system having a compact form factor can be provided.

  The device shown is a reusable pen-type drug injection device, generally designated 100, which selectively sets the dose and then manually injects the set dose by the user. Handled by Since the sensing system can be adapted for use with variously configured drug delivery devices, including differently configured pen-type drug injection devices, differently shaped injection devices, and infusion devices, the description of device 100 is merely a matter of course. It is an example. The drug can be any of the types that can be delivered by such a drug delivery device. The device 100 is intended to be illustrative and not limiting, as the sensing system described further below may be used in other differently configured devices. Device 100 is similar in many respects to the device described in US Pat. No. 7,195,616, which is incorporated herein by reference in its entirety.

  As used herein, the term "coupled" refers to any manner in which a first article is moved simultaneously with or in proportion to a second article as the second article moves. Include. When the articles are rotated together, the articles are rotatably coupled. The coupling system may include, for example, connections provided through splines, gears, or frictional engagement between the members, or similar connections provided by other components that indirectly couple the members. Where applicable, the article is positioned directly on, contained within, attached to, or integrated with, or otherwise directly or indirectly to, another article. By being securely fixed, it can be connected to another article.

  The term "fixed" is used to indicate that the indicated movement may or may not occur. For example, if the first member is unable to rotate with respect to the second member, the first member may be "rotatably secured" with the second member, or may rotate with respect to the second member. Fixed. "

  Drug injection device 100 includes an outer housing that supports the internal components of the device. The housing is shown as having a rear or main housing 102 and a front or cartridge housing 104. The main housing 102 is configured to hold the drive assembly of the device, which is a mechanical assembly that is strictly user powered as described, but in an alternative embodiment is an electric assembly. You may. A cartridge housing 104, also known as a cartridge retainer, holds a drug-filled cartridge 106 delivered by device operation. The cartridge retainer 104 is attached to and detached from the main housing 102 via a male thread 110 on a raised collar portion 112 of the main housing 102 that mates with a female thread 114 on a ring portion 116 at the proximal end of the cartridge retainer 104. Can be connected or mounted as possible. Suitable detachable connection elements other than threads 110 and 114, such as bayonet fittings or the use of additional latch components, are known in the art and may be employed, of course.

  The cartridge retainer 104 includes an internal cavity 105 suitable for removably receiving the cartridge 106, whereby the cartridge is inserted therein and then depleted and replaced with a new cartridge of a similar design. It can be removed from it when done. An opening 118 in the cartridge retainer 104 allows visibility of the contents of the cartridge. A detent mechanism 120 external to the cartridge retainer 104 allows a protective cap (not shown) to be removably mounted on the cartridge retainer 104 when the needle assembly 125 is not attached to the cartridge retainer 104. To Although the cartridge retainer 104 is described herein as a reusable component, the cartridge retainer 104 may be integral with the cartridge 106 and thus may be disposable with the cartridge 106.

  The drug cartridge 106 has a drug-filled internal reservoir sealed at one end by a slidable plunger or piston 132 and sealed at the other end by a septum 134 held by a crimp ring 136. Of a conventional design including a barrel 130 having

  A needle assembly 125 that is removably attachable to the externally threaded distal end 122 of the cartridge retainer 104 pierces the septum 134 when so attached. The pierced septum through which the needle extends extends to serve as an outlet during dispensing of the medicament in the reservoir of barrel 130, which is delivered through needle assembly 125 by operation of device 100. You. The cartridge 106 can hold multiple doses of the drug, or even a single dose, depending on the purpose of the device 100.

  The drug injection device 100 is shown in FIG. 1 in its "zero position" where the device is not set for delivery of any dose. This zero position setting is indicated, for example, by the number "0" visible somewhere on the device, such as the electronic dose display 140 of FIG. In FIG. 2, the device 100 is prepared after being operated to set a dose of 30 units for delivery, and the number “30” becomes visible, for example, on the display 140.

  The drug injection device 100 includes a number of such reusable, including a manually powered dose delivery mechanism, generally designated 150, that controls the forward or distal advancement of the drive member, generally designated 160. Typical of the device. Drive member 160 advances within cartridge barrel 130 to directly engage plunger 132 and advance it. As shown in FIG. 2, the dose delivery mechanism 150 includes a dose knob 152 connected via a tube 154 to a mechanical drive assembly, designated at 156, housed within the main housing 102. Including. As the user turns knob 152 to set the dose for injection, dose knob 152 and tube 154 are screwed together proximally from main housing 102. When the user pushes the proximal end 158 of the dose knob 152 and applies a distal force, the resulting pure translational axial movement of the dose knob 152 and tube 154 distally into the main housing 102 is , By the drive assembly 156 is converted to a smaller movement of the drive member 160 forward from the main housing 102 to the interior of the cartridge barrel 130.

  The drive member 160 is formed of two parts, including a front end 163 that directly engages the cartridge plunger 132 and a shaft 165 that extends axially rearward from the front end 163 into the main housing 102. . Shaft 165 is threaded and engages drive assembly 156 and is threaded from main housing 102, thereby being driven forward. Shaft 165 is shown in threaded engagement with housing blocking wall 168, which is shown integrally with main housing 102, but which is separately formed and fixedly attached thereto. Can also. The forward end 163 is provided in the form of an enlarged diameter foot mounted on the shaft 165 to allow for relative rotation, such that when the shaft 165 is screwed in, the foot 163 will move relative to each other. Allows engagement with plunger 132 without rotation. This two-part foot and shaft configuration of the drive member 160 is preferred when the shaft 165 is screwed out of the housing during advancement, but especially when the drive member simply translates when pushed forward from the housing. Such a structure is not required for the device, in which case a single part drive member structure may be more acceptable.

  Device 100 uses an electronic dose display 140 rather than a spirally marked dial display as used in many other reusable injection devices. Display 140 is connected to and controlled by an electronic controller or computing assembly 170 mounted within main housing 102. Controller 170 may include conventional components such as a processor, power supply, memory, and the like. The controller 170 is programmed to achieve the electronic features of the device 100, including causing an indication of the set dose. The set dose displayed on the display 140 is determined by the interaction of the dose delivery mechanism 150 with the sensing system, which is electrically connected to the controller 170, shown abstractly at 175.

  Still referring to FIGS. 3-5, the sensing system 175 is relatively rotatable in proportion to such set dose when the dose is set by a user screwing the dose knob 152 out of the housing 102. It is connected to two members of a device 100. Depending on the configuration of the device 100, and in particular the drive assembly 156, these two members of the device 100 to which the sensing system 175 is also coupled will also each have a proportionate dose delivered by the depressing operation of the dose knob 152. May be rotatable relative thereto, in which case the sensing system 175 can be further used for determining the delivered dose. Alternatively, in another embodiment where the delivered dose is sensed instead of the dose setting, the sensing system 175 is relatively rotatable in proportion to the amount of dose delivered during dose delivery. Positioned to sense the dose delivered by being coupled to the two members of device 100, neither of the two members rotates relative to each other during dose setting.

  The sensing system 175 operates to detect the relative rotational position of the first and second device members to which it is coupled and produces an output that is correlated to such relative rotational position. The sensing system 175 includes a sensing band 180 and a wiper 185. In device 100, sensing band 180 is coupled to housing 102 and wiper 185 is coupled to a portion of drive assembly 156 that rotates within the housing at a selected time of use of the device. Alternatively, the sensing band 180 may be coupled to the housing 102 via one or more intermediate components, and still alternatively, for example, when the wiper 185 with which it engages moves axially during use of the device. However, such as when the sensing band 180 is rotatably secured to the housing 102 and directly attached to an axially movably mounted component, it does not rotate directly or directly with respect to the housing but does not May be coupled to the housing 102 to move freely.

  As shown abstractly in FIG. 3, the sensing band 180 is directly attached to the inner circumferential and radially inwardly facing surface 188 of the housing 102, such as by an adhesive, while the wiper 185 is attached to the drive assembly 156. Is attached directly to a portion of the radially outer surface 190, such as with an adhesive or by being integrally formed therewith. The drive assembly 156 can take various forms, but typically includes a plurality of interacting portions, and the wiper 185 is positioned on a rotatable portion of the assembly such that it has direct contact access to the sensing band 180. Shown.

  The wiper 185 includes a body 196 that projects radially outward from its inner end 194 to its outer end 198. Outer end 198 has a rounded apex that provides a precise point of contact for sliding engagement with sensing band 180 along the circumferential extent of the band. The wiper body 196 has a length extending in an axial direction parallel to the rotation axis designated 200, around which the wiper rotates the portion of the drive assembly 156 from which it projects. The wiper 185 may be formed entirely of a non-conductive material, such as a thermoplastic elastomer, such as silicone, since no current is conducted therethrough.

  The wiper may alternatively be a single point contact, having no axial length as shown. The wiper does not need to be widened to extend in the sensing band 180 in the axial direction of the resistive strip. Providing the wiper 185 with an axial length can account for both tolerances within the design of the device and axial movement of the wiper 185 relative to the sensing band 180 and the housing 102 within the device.

  The emission height of the wiper body 185 is designed to span an annular space or gap 202 inside the housing between the sensing band 180 and the drive assembly 156. The wiper 185 projects far enough radially outward to provide at least minimal applied force, thereby operatively engaging the sensing band 180 as described further below. Such forces can be controlled by the manufacturer through the choice of materials and processes such as tempering, and the geometry of the wiper and its residual compressive strength in 156. At all angular positions of the drive assembly 156 and thus the wiper 185, the wiper 185 is biased radially outward from the drive assembly 156 to further ensure proper engagement of the sensing band 180 with the housing 102. be able to. Such biasing is provided by the elasticity of the material resulting from forming the wiper 185 from a durable but elastic material, such as a thermoplastic elastomer or butyl rubber, with a suitable durometer. Can be The bias may additionally or alternatively be provided by an additional spring element acting radially between the wiper 185 and the drive assembly 156. Still further, radial inward biasing of the sensing band, such as by disposing a spring element to act radially between the radial outer periphery of the sensing band and the radially inner radial surface of the housing, is an alternative or alternative. It may be additionally performed.

  Wiper 185 and sensing band 180 are radially aligned when operating to sense relative rotational position. For example, in a device embodiment where the drive assembly 156 moves axially from one state in which the sensing system 175 is not used to a second state in which the sensing system 175 is used, the wiper 185 and the sensing band 180 are used. If not, they can be separated axially.

  Other wiper shapes than those shown in FIG. 3 can be used to activate the sensing band 180. Such additional wiper shapes include rounded protrusions, or pivoted disks or cylinders, which result in rolling contact with the sensing band 180.

  Sensing band 180 is configured to generate an electrical output based on where wiper 185 directly contacts along its angularly extending operating length. The sensing band 180 is arranged in the housing 102 in a curved shape around the rotation axis 200, and the band is arranged radially outside the wiper 185. The sensing band 180 is shown in FIG. 3 as an annular shape so as to extend all 360 degrees around the inner circumference of the housing and completely surround the axis of rotation 200. Alternatively, sensing band 180 may be a ring shape that does not completely surround or surround the axis of rotation.

  The sensing band 180 may be formed by a membrane variable resistor manufactured in a curved shape to facilitate assembly within the device 100 to remove residual stress. One suitable sensing band is available from Tekscan Incorporated. The membrane variable resistor is an assembly of components that are shown abstractly in the uncurved state in FIG. 6, but the radiation and angle descriptions are in the rounded configuration shown in other figures. Of the sensing band. The sensing band 180 includes first and second substrates or backing strips 205, 207 and first and second electrical strips 209 and 211 sandwiching a spacer 213. The substrates 205 and 207 and the spacer 213 are made of a non-conductive flexible plastic such as PET (polyethylene terephthalate) or a polyimide film such as Kapton. Alternatively, the spacer 213 can be a printing material directly deposited on either the substrate 205 or 207 by means such as screen printing. The spacer 213, which helps keep the electrical strips 209 and 211 apart without sufficient force applied by the wiper, can also have an adhesive property to connect the substrates 205 and 207 to each other. The outer edges of the substrates 205, 207 and the spacer 213 form the outside of the sensing band 180 and, when sealed together along their peripheral area, protectively wrap the strips 209 and 211. The strips 209 and 211 are fixed to the substrates 205 and 207 and / or the spacers 213 or can be formed in another way, for example directly on the substrate, such as by screen printing.

  When in the neutral state, the electrical strips 209 and 211 are held in the sensing band 180 in spaced relation by the interposition of the spacer 213. When the band 180 is in its curved configuration within the device 100, the strip 209 is positioned radially inward of the strip 211, and without external force the strips 209 and 211 are radially separated while the electrical connection therebetween. Does not occur. In this radially spaced relationship, strips 209 and 211 are directly facing (facing) each other via a central slot-shaped opening 214 in spacer 213. A dielectric projection (not shown) is provided on one of the electrical strips 209 or 211 in the opening 214 to ensure that the strips 209 and 211 remain radially separated without movement by the wiper. You can also. Such protrusions are discontinuous ridges arranged in a polka dot pattern, parallel ribs oriented in the axial direction, spaced apart from one another along the width of the strip and along the length of the strip, relative to the strip width. Parallel ribs that are angled and spaced from each other across the strip width and along the length of the strip, or circumferentially oriented along the length of the strip and spaced from each other along the width of the strip It can be provided by any suitable pattern that maintains the radial spacing of the strips, such as parallel ribs, such as by screen or jet printing.

  Electrical strip 211 is an electrical resistance element having an electrical resistance that varies linearly along its length extending from first corner end 218 to second corner end 220. A first electrical lead 222 connects to end 218 and extends therefrom, and a second electrical lead 224 connects to end 220 and extends therefrom. Lead 224 is wired to lead end 228 parallel to lead 222 at 226 near the electrical strip side, which facilitates electrical connection between sensing band 180 and device circuitry.

  The electrical strip 209 is made of silver, copper or gold, has a length extending from the first corner end 230 to the second corner end 232, and has a very low electrical resistance. It is. A first electrical lead 235 connects to end 230 and extends therefrom.

  Although leads 235, 222, and 228 are shown as being located on extensions of substrates 205 and 207 that extend angularly along the length of such substrates, in alternative embodiments, Such leads may be wired to alternate or additional substrate portions extending laterally or axially from the substrate, to facilitate electrical connection.

  Strip 209 is sufficiently flexible along its length to allow direct radial and outward deflection at the point where wiper 185 has acted through substrate 205 to make direct physical and electrical contact with electrical strip 211. Make it possible. This wiper causes the wiper 185 to be compressed by causing the strip 209 to deflect radially outward, as shown at 219 in FIG. 3, thereby creating an electrical contact between the strips 209 and 211. Operatively engages the sensing band 180, but otherwise leaves the strips radially spaced. The resistance between electrical leads 235 and 222 varies linearly with the distance between corner end 218 and the point of contact between strips 209 and 211. The resistance between the electrical leads 235 and 228 varies linearly with the distance between the second corner end 220 and the point of contact between the strips 209 and 211. The resistance between electrical leads 222 and 228 is equal to the sum of the electrical resistance between leads 235 and 222 and the resistance between leads 235 and 228.

  In an alternative embodiment, if the resistive element 211 has a flexibility characteristic similar to that of the conductor element 209 to allow deflection due to wiper engagement, the sensing band 180 will replace the resistive component 211 with the device shown. It can be configured to have on the radial inside of 100 conductor elements 209.

  The sensing band 180 has been removed from the rest of the device 100 and is shown in FIG. The sensing band 180 is wrapped precisely circumferentially around the axis of rotation 200 to minimize the use of axial space in the device 100 dedicated to the sensing system 175. Alternatively, band 180 may be axially offset at its ends such that band 180 is arranged in a spiral. The sensing band 180 is operable to sense the wiper 185 at any point along the angular length of the sensing band 180 where the electrical strips 209 and 211 are present, and due to the radial deflection caused by the wiper 185, Can make electrical contact. Sensing band 180 has electrical properties that, due to physical contact with wiper 185, correlate along its operating angle length with where it is operatively engaged.

  In the illustrated embodiment, the operating angular length of the sensing band 180 for which sensing is effective is less than 360 degrees about the axis of rotation 200 to wrap the band 180. This length is due to the end region 236 of the spacer 213 proximate to the first end 237 of the band 180, where no sensing occurs. This spacer end region 236 overlaps the second end 238 on the opposite side of the band 180, and the sensing band 180 provides a useful portion of the electrical strips 209 and 211 adjacent to the opposite end region 239 of the spacer 213. It is sized to be large and does not overlap angularly with the spacer end region 236, but stops just before such overlap as shown in FIG. As a result, the operating angle length extends less than 360 degrees around the inner circumference of the housing, particularly 360 degrees minus the portion of the inner circumference covered by the spacer end region 236. One suitable operating length extends at least 345 degrees. In an alternative embodiment where the sensing band 180 is longer, the effective length of the electrical strips 209 and 211 can overlap the end region 236.

  The controller 170 includes a microprocessor 240 electrically connected to the sensing band 180, as shown schematically in FIG. The electrical output from the sensing band 180 reaching the microprocessor 240 is set by operation of the device 100 based on, among other things, the microprocessor 240 determining the associated movement of the drive assembly 156 relative to the main housing 102 during dose setting. Processed by the microprocessor to identify the amount of the administered dose.

  As shown in FIG. 8, a power supply 250, such as a 1.8 volt power supply, housed within the device 100 in the controller 270 includes a lead 222 from a resistive element 211 that acts as an input to the sense band 180. Are connected by a node 242 having The output lead 235 of the conductor element 209 is connected to an input port 258 of the microprocessor 240 which is electrically grounded via a signal amplifier 260 at a node 256. Node 256 is grounded through a voltage divider resistor 262 to provide a voltage to microprocessor 240 that is proportional to the resistance between nodes 256 and 242. Output lead 228 of resistive element 211 is connected to a second input port 246 of microprocessor 240 which is electrically grounded via signal amplifier 250 at node 244, and node 244 is connected between node 244 and node 242. Is grounded via a voltage dividing resistor 252 to supply a voltage proportional to the resistance of the microprocessor 240 to the microprocessor 240.

  The voltage signal received by the microprocessor 240 via the node 256 depends on where the wiper 185 contacts the resistive element 211 due to the deflection of the conductive element 209 along the angular length of the resistive element 211, 170 can determine the relative position of the member sensed by the sensing system 175, ie, the drive assembly 156 and the housing 102.

  The circuitry shown provides the differences provided at inputs 246 and 258 to microprocessor 240 that can be used to compensate for any fluctuations in the output of sensing band 180 that may occur over time or due to environmental conditions. Resulting in a dynamic voltage signal. In an alternative embodiment, such a circuit differential signal may not be required with a sense band.

  If the operating angle length of the sensing band 180 is less than 360 degrees, a sensing gap is created around the inner circumference of the housing. Unless the wiper has an angular length greater than the sensing gap, there is a time during the circumferential movement of the wiper where the presence of the wiper 185 cannot be actually sensed by the sensing system 175. Controller 170 can be programmed to understand that sensing system 175 that does not output wiper engagement actually corresponds to wiper 185 that is aligned with the sensing gap. If such programming is not desired, or if the sensing gap is greater than the angular resolution required for a particular application, an alternative sensing system can be used.

  One such alternative sensing system is shown abstractly in the relevant part of FIGS. The sensing system, designated generally at 175 ', can be used in place of the sensing system 175 in the device 100 to sense the relative position between the housing 102 and the drive assembly 156. The sensing system 175 'includes first and second sensing bands, 180a and 180b, each structurally identical but not electrically connected to each other, with the sensing device 180 electrically connecting to the device controller. including. The sensing bands 180a and 180b are coaxially arranged, each presenting a precise circumferential arrangement about the axis of rotation 200. Sensing bands 180a and 180b are axially spaced apart such that the electrical strips of each band 180a and 180b are not in axial overlapping relationship with other electrical strips.

  Sensing band 180a includes a resistive element 211a and a conductive element 209a, and sensing band 180b includes a resistive element 211b and a conductive element 209b. The operating angular length of each of the bands 180a and 180b is shown in FIG. 9 as well as the band 180, and each such length extends only partially around the circumference of the drive assembly 156. . Such a configuration results in a sensing band 180a having a sensing circumferential gap 181a and a sensing band 180b having a sensing circumferential gap 181b. The effective lengths of bands 180a and 180b are shown as being equal, but this is not necessary as long as one detection band covers the other sensing circumferential gap.

  The wiper of sensing system 175 'is shown as a single axially extending component 185' that engages both sensing bands 180a and 180b. Different axial areas of the wiper 185 'engage different sensing bands 180a and 180b. In an alternative embodiment not shown, the wiper need not be a single continuous member, as shown in FIG. 10, but may instead be two different wipers, or optionally a sensing band. There may be a break along its axial length that does not interfere with the action of engaging 180a and 180b.

  The sensing bands 180a and 180b are angularly staggered as shown in FIG. 9 so that the sensing circumferential gaps 181a and 181b are not axially aligned at all. As a result, when the wiper 185 'is oriented to be located within the angular gap 181a, the wiper 185' will simultaneously and necessarily engage the sensing band 180b and attempt to operatively engage within the gap 181b. Not positioned to be. The controller 170 is programmed such that the wiper 185 'is understood from the combination of outputs from the sensing bands 180a and 180b located relative to the housing 102, and thus the drive assembly 156. The controller 170 can also use the output combination to determine if one of the sensing bands is not operating properly.

  The sensing bands 180a and 180b are shown in FIGS. 9 and 10 as being separately formed and positioned within the device. In another configuration, the resistance elements, conductor elements, and leads of the two sensing bands shown can all be provided on a common substrate of appropriate size and shape and with appropriate common spacers. This structure consists of two sets of resistor and conductor elements that are angularly staggered, each set having its own electrical contacts to connect to the device controller, but not to the other set, This results in a single sensing band that can be treated as one unit.

  In yet another alternative embodiment not shown, the sensing circumferential gaps of two or more sensing bands can be axially aligned. However, the wiper element has portions on different axial elements of the drive assembly 156, and the wiper portions are properly angled about the drive assembly 156 so as not to simultaneously engage with the sensing gaps of the plurality of sensing bands. Separated.

  Referring now to FIG. 11, an alternative drug delivery device with a sensing system is shown in a perspective view. The sensing system is incorporated into a dose delivery detection module, generally designated 400, which is removably mounted over the proximal end of the remainder of the delivery device, generally designated 405. When the module 400 is mounted as shown, its sensing system, which is represented abstractly at 410 in FIG. 11, detects the relative rotational position of the module housing portion and thereby the device portion during dose delivery. The relative rotational position of the first and second members at 405 produces an output that correlates to such relative rotational position used by controller 415 to identify the dose delivered by operation of the device.

  FIG. 12 shows the module 400 before detachable attachment to the device portion 405 or after removal from the device portion 405.

  With further reference to FIG. 13, the sensing system 410 includes a wiper 420 and a sensing band 425. The wiper 420 is coupled to the inner peripheral surface 432 of the module housing part 450 and projects radially inward therefrom. The sensing band 425 is coupled to and surrounds the radially outer or outer surface 434 of the module housing portion 455. Detection band 425 is in an amount equal to the axial offset shown in FIG. 13 and is slightly less than the axial center of wiper 420 for housing portion 455 to move axially down relative to housing portion 450 during dose delivery. Shown in FIG. 13 as being axially offset upwards, which shows the device configured prior to dose setting. During dose delivery, sensing band 425 and wiper 420 are completely radially aligned. The sensing band 425 is electrically connected to a wiring (not shown) to a controller 430 fixed in the internal hollow portion 457 of the housing portion 455. Other than the reversal of the radial position of those and components described herein, and such configurations are for sensing the delivered dose instead of the set dose as described further below. And the wiper 420, sensing band 425 and controller 430 are configured and function similarly to the corresponding wiper 185, sensing band 180 and controller 170 of the device 100.

  Module housing portion 450 includes a connection 460 that is complementary shaped to skirt 500 of dose dial assembly 502 for releasable attachment of module 400 to the rest of delivery device 405. The skirt 500 is formed separately from the dose dial assembly 502 but is rotatable and axially fixed, and the connection 460 allows the housing 450 to rotate and rotate relative to the dial assembly 502. Fixed in the direction. The module housing portion 455 includes a base surface 465 that is rotatably fixed by engaging with the upper surface 504 of the button 506.

  To set up the device of FIGS. 11-13 for delivery, the module 400 is rotated with respect to the pen housing 508, thereby screwing the dial assembly 502 and button 506 up and together with the pen housing 508. A spline connection, shown at 464, between housing parts 450 and 455 helps keep these housing parts rotating together during dose setting.

  In order for the device of FIGS. 11-13 to deliver a set dose, the housing portion 455, like the button 506, is pressed by the user by pushing the upper surface 470 of the housing portion 455 into the housing portion 450 and the dial assembly. Move downward without rotating with respect to. This movement disconnects the spline connection 464, as well as the clutch connection not shown between the button 506 and the dial assembly 502, causing the alignment of the sensing band 425 with the wiper 420. A further push will simultaneously screw housing portion 450 and dial assembly 502 into pen housing 508 while moving housing portion 455 and button 506 axially downward without rotation. The relative rotation of housing portions 450 and 455 is sensed by the operative interaction between wiper 420 and sensing band 425 so that controller 430 can determine the delivered dose.

  Device portion 405 may be equivalent to Humalog® KwikPen® from Eli Lilly and Company taught in US Pat. No. 7,291,132, the entire contents of which are incorporated herein by reference. Incorporated in Further details of the dose delivery detection module 400 are properly understood from US Provisional Patent Application Ser. The entire contents are incorporated herein by reference.

  Referring now to FIGS. 14-21, relevant portions of an alternative drug delivery device having a sensing system, generally designated 600, are shown. The sensing system of device 600 is configured to determine both the dose set and the dose delivered by operation of the device.

  Device 600 may be configured similarly to device 100, except for obvious differences from the following description and the associated figures. As well as further details of a sensing system suitable for such a type of mechanical drive assembly, the description of device 600 includes further details of the configuration of that mechanical drive assembly corresponding to assembly 156 of device 100. References to the same components as device 100 use the same reference numbers used for device 100 for ease of description.

  Referring first to FIG. 14, the device sensing system generally designated 620 is visible within the housing compartment 622 because a portion of the outer main housing 624 has been removed. Housing section 622 is shaped to receive sensing system 620 and projects radially inward to support core member 650 and maintain it rotationally and axially fixed with respect to housing 624. Alignment ribs 644 and 646 are provided.

  The sensing system 620 selects members of the device 600 that are relatively rotatable in proportion to the set dose and are relatively rotatable in proportion to the dose injected or delivered. To be combined. These members include a barrel 660, a drive sleeve 665, and a core member 650.

  Still referring to FIGS. 15 and 16, the barrel 660 is a sleeve that is tightened so as to rotate with the tube 154 but move axially relative thereto. Drive sleeve 665 includes a male thread 670 that engages the female thread of tube 154. The internal shaft cavity 672 of the drive sleeve 665 receives the threaded shaft 165 therein. The unillustrated tightening between the drive sleeve 665 and the threaded shaft 165 causes the rotation of the drive sleeve 665 within the housing section 622 to cause a corresponding rotation of the shaft 165, which causes the shaft to advance axially and the device 600 means to discharge the drug.

  As the knob 152 and tubing 154 are rotated axially together from the device housing during dose setting, a spline connection (not shown) between the device housing 624 and the drive sleeve 665 causes the drive sleeve to rotate. 665 does not rotate about axis of rotation 674, while barrel 660 rotates within housing 624 about axis of rotation 674.

  When the dose knob 152 is depressed by the user to deliver a dose, the depression first causes a translational translation of the drive sleeve 665 due to the axial force transmitted by the tube 154 at the external thread 670. This causes a translational translation of the barrel 660 by the axial force transmitted by the sleeve flange 673 to the barrel shoulder 675. Since the torque required to overcome a spring-loaded housing-engaged dose clicker (not shown) splined to barrel 660 is greater than the torque generated at thread 670, this transition motion Do not rotate tube 154 and barrel 660. This translation, which occurs against the resistive axial force provided by the clicker spring (not shown), breaks the spline connection (not shown) between the device housing and drive sleeve 665, while spline 676 of barrel 660. Are moved into engagement with complementary housing splines not shown in the axial direction. Further user depression of the dose knob 152 causes the drive sleeve 665, and thus the shaft 165, to rotate about the axis of rotation 674 and the drug is released, while the barrel 660 is rotated about the axis of rotation 674 by a spline connection with the housing. Does not rotate.

  With further reference to FIGS. 17 and 18, sensing system 620 includes sensing bands 680 and 700. The sensing band 680 includes a wiper sensing portion 682 formed in a cylindrical sleeve shape, and a connector foot 684. Sensing portion 682 is a single piece that includes two angularly staggered conductor-resistor strip pairs that extend circumferentially within the sleeve, similar to those described above for sensing bands 180a and 180b. It is an assembled unit. Alternatively, the sensing portion 682 can be configured similarly to the sensing band 180. Connector leg 684 includes electrical leads connected to two associated conductor-resistor strip pairs. Connector leg 684 includes a first region 686 that extends axially directly from sensing portion 682. The transition region 688 extends angularly from the first region 686 and can be a printed extension of the lead end 228 and can connect to an electrical lead, such as a ZIF (Zero Insertion Force) connector. , Terminating in an end region 690 containing electrical connections not shown and connected to a conductor-resistor strip pair of the sensing portion 682. Electrical connections are provided on the radiating perimeter of the end region 690 for electrical connection during assembly with the circuitry directed to the controller of the device 600. First region 686 is located in the same curved plane as sensing portion 682, while transition region 688 extends radially outward from first region 686. End region 690 extends from transition region 688 and covers the outside of the core member to allow electrical connection to other circuits that can transition to a flat connection.

  The sensing band 700 includes a wiper sensing portion 702 formed in a cylindrical sleeve shape, and a connector leg 704. The wiper sensing portion 702 has a larger diameter than the wiper sensing portion 682 and fits around. Sensing band 700 is a single assembly unit that includes two angularly staggered conductor-resistor strip pairs that extend circumferentially within the sleeve, similar to those described above for sensing bands 180a and 180b. However, typically the conductor strip is located radially outward of each resistive strip. Alternatively, the sensing portion 702 can be configured similarly to the sensing band 180, typically reversing the resistance and the conductor strip. Connector leg 704 includes electrical leads connected to two associated conductor-resistor strip pairs. Connector leg 704 includes a first region 706 that extends axially from sensing portion 702 and directly into the same curved plane as sensing portion 702. Transition region 708 extends angularly from first region 706 with an offset and extends radially outward, allowing the service loop to assist in connecting 710 to other circuits. End region 710 of connector leg 704 extends in a curved shape from transition region 708 to cover the outside of the core member and extends within connector leg 704 as described above with respect to end region 690. Includes electrical connections (not shown) for electrical connections during assembly with the circuitry wired to the controller of device 600 on its outer radiating periphery connected to the electrical leads.

  The core member 650 is formed of a piece of hard plastic and includes an internal hole or hollow penetration 652. The core member 650 has a sleeve portion 720 having a cylindrical radial inner or inner surface (inner surface) 722 and a cylindrical radial outer or outer surface 724. Core member 650 includes a clamping portion 730 at the distal end of sleeve portion 720. The clamping portion includes a cylindrical radial inner surface 732 that is an axial continuation of the sleeve portion surface 722. The radially outer surface 735 has a grooved section 736 that fits over the alignment ribs 644 and 646 to provide alignment for placement within the housing compartment 622 so that during use, the core member 650 is positioned within the housing 624. Prevent rotation or movement in the axial direction. The core member 650 is shown as a single piece that is effectively connected to the housing and does not require such a design, but facilitates manufacture and assembly. In an alternative embodiment, the core member may be formed integrally with the outer housing or may be formed from a plurality of parts assembled together and then installed in the housing.

  The sensing bands 680 and 700 are mounted on the core member 650 so as to be rotationally and axially fixed to the core member 650, respectively, and thus are indirectly axially and rotationally fixed to the housing 624. Such attachment may use adhesives or alternative methods such as mechanical fasteners or friction fits.

  The sensing band 680 is arranged such that the wiper sensing portion 682 wraps or overlaps the entire circumference of the cylindrical radial inner surface 722 such that the connector leg first region 686 is cylindrical inner surface. Extending along 732, the transition region 688 fits through a slot-shaped opening 740 provided through the fastening portion 730 by a notch 742 at its distal end 744, and the end region 690 is Cover the radial outer peripheral surface 735.

  Sensing band 700 is arranged such that wiper sensing portion 702 is radially aligned with wiper sensing portion 682 and radially outwardly, and the two sensing layers provided by sensing bands 680 and 700 are combined with core sleeve portion 720. Sandwich the core sleeve portion 720 directly between them so that they are separated only by The wiper sensing portion 702 wraps around the entire circumference of the cylindrical radial outer surface 724 with the connector leg first region 706, transition region 708, and end region 710 covering the radial outer surface 735 of the tightening portion 730. Stick.

  A wiper element 750 coupled to a drive sleeve 665 extending through the core hole 652 is located radially inward of the wiper sensing portion 682 and is in sliding engagement therewith. The wiper element 750 is rigid and has a suitable axial length to effectively engage the wiper sensing portion 682 at any time during device operation. Such a design allows the rotational position of the drive sleeve to be checked even when it must not rotate during dose setting. The wiper element 750 projects radially outward from a stepped arm 752 that extends axially from a C-shaped clip or mount 754. A notch or depression 675 around the wiper element 750 and the drive sleeve 665 under the arm 752 serves as clearance for the arm 752 to flex.

  Although the wiper element 750, arm 752 and clip 754 are shown as integrally formed, they can be formed and assembled separately. The material of arm 752 and clip 754 can be pressed stainless steel that provides sufficient resilience to the deflection of arm 752, which deflection provides a spring-loaded engagement between wiper element 750 and sensing band 680. While taking into account the non-concentricity and the attachment of the clip 754 to the drive sleeve 665. The wiper clip 754, and thus the arm 752 and the wiper element 750, are rotationally and axially fixed to the drive sleeve 665 via a protrusion 758 of the drive sleeve 665 that fits tightly into the complementary hole 760 of the clip 754, The resiliency of the C-shaped clip 754 wraps around the drive sleeve 665 radially. As shown in FIG. 19, during manufacture and assembly of the clip 754 into the drive sleeve 665, when the clip 754 is slid axially over the drive sleeve 665 as indicated by the arrow 753, the clip 754 is resilient by a wedge 770. 20, the hole 760 is over the protrusion 758 and the axial position clip 754 passes through the wedge 770 so that the clip 754 snaps back around the drive sleeve 665, as shown in FIG. It is then moved axially to fit over it.

  A wiper element 780 coupled to barrel 660 is positioned radially outward of wiper sensing portion 702 and slidably engages. As shown in FIG. 16, the wiper element 780 can extend in a different axial direction than the wiper element 750. As shown in FIG. 16, the wiper elements 780 can be separated by sidewalls of the sleeve portion 720 of the core member 650 and overlap the wiper elements 750 in a radial direction. Wiper element 780 is positioned radially outward from wiper element 750. The wiper element 780 is rigid and has an axial length suitable to effectively engage the sensing band 700 at any time during device operation. Such a design allows the rotational position of the barrel to be checked even when it must not rotate during a dose injection. The wiper element 780 projects radially inward from a stepped arm 782 extending axially from a C-shaped clip 784. Although the wiper element 780, arm 782, and clip 784 are shown as integrally formed, such as from stamped stainless steel, they can be formed and assembled separately. Arm 782 is flexible and provides spring-loaded engagement between wiper element 780 and sensing band 700, allowing for non-concentricity.

  The wiper clip 784, and thus the arm 782 and the wiper element 780, are rotatably secured to the barrel 660 by a clamping connection using the notch 790 of the clip 784 and the space 792 between the ends 793 of the two clip legs, It securely receives two inwardly projecting tongues 794 into the hollow portion 798 of the barrel 660. The wiper clip 784 and thus the arm 782 and the wiper element 780 snap fit into the recess 799 in the barrel inner surface, but extend axially, such as by using a mechanical fastener such as an adhesive or radial crimp. Shown axially secured to barrel 660 by locking spring 797.

  As will be appreciated from the above understanding of the operation of the device 600, the relationship between the wiper element 780 and the sensing band 700 has been set in the device 600 by sensing the rotation of the barrel 660 relative to the core member 650 and the housing 624. The dose can be identified by the controller, and the relationship between the wiper element 750 and the sensing band 680 senses rotation of the drive sleeve 665 relative to the core member 650 and the housing 624 to determine the dose delivered to the device 600. Allows identification by the controller.

  Referring now to FIGS. 23-25, relevant portions of an alternative drug delivery device with a sensing system are shown. Like device 600, the device of FIGS. 23-25 is also configured to determine both the set dose delivered and the dose delivered by operation of the device. The devices of FIGS. 23-25 use a modified sensing band having different areas of a typical electrical strip that cooperate with a pair of wiper elements. It will be appreciated that the device of FIGS. 23-25 may be similar in overall operation to device 600.

  The device comprises a barrel 850, a drive sleeve 860 that transmits its rotation to a threaded shaft, not shown, used to release the medicament via a mechanical drive train, not shown, and a device housing 860. A core member 890 that is rotatably fixed and is not axially restrained with respect to the device housing so as to be able to slide axially with respect to the device housing.

  A wiper assembly, generally referenced 880, is fixedly coupled to the drive sleeve 860 and rotates with and moves axially therewith and extends into the bore 898 of the core member 890. The wiper assembly 880 includes a pair of wipers 882 and 884, each formed of a wiper element on a flexible arm. The wiper elements of wipers 882 and 884 are shown as outwardly convex surfaces projecting from the arms, but need not be of such shape or protrusion. Wipers 882 and 884 extend axially from a C-shaped clip or mount 886 at a position 180 degrees from each other and are integrally formed therewith. The wiper 882 extends more axially from the mount 886 than the wiper 884, as further described below. The wiper 882 can flex within the depression 862 of the drive sleeve 860, while the wiper 884 can flex within the depression opposite the depression 862 of the drive sleeve 860 as well. Since the wiper mount 886 is fixed about the shaft portion 863 of the drive sleeve 860, the wiper assembly 880 rotates with the drive sleeve, and the wiper assembly 880 is moved through a shoulder 861 formed on the drive sleeve 860. It does not move axially with respect to the drive sleeve 860, such as due to axial capture of the wiper mount 886 and frictional interactions on the inner surface of the wiper mount 886.

  The wiper assembly, generally referenced 870, is fixedly coupled to barrel 850 in a suitable manner for rotating therewith and moving axially therewith. The wiper assembly 870 includes a pair of wipers 872 and 874, each formed from a wiper element on a flexible arm. The wiper elements of wipers 872 and 874 are shown as the strip engaging surfaces of the respective wiper arms, but can protrude from such arms. Wipers 872 and 874 extend from and are integrally formed with the wiper ring, the ring forming a clamping portion that fits snugly within the angular space between opposing corner ends of arcuate extension 854 of barrel 850. 876 is shown. Wipers 872 and 874 are circumferentially disposed at substantially 180 degrees (ie, within a range of 180 degrees plus / minus 10 degrees) with respect to each other. In one embodiment, wipers 872 and 874 extend axially 180 degrees apart from each other. As described further below, the wipers 874 extend further axially forward than the wipers 872 (ie, are axially offset from one another).

  As drive sleeve 860 and barrel 850 move together axially within the device housing during the mode transition of the device, core member 890 is forced to move axially with drive sleeve 860 and barrel 850. In the illustrated embodiment, when the device transitions from the dial mode to the injection mode, the core member 890 is driven forward in the device housing by the thrust surface of the wiper assembly 870. Clip 920 is an axial thrust washer / clip that locks onto drive sleeve 860 and is used to pull core member 890 back into the device housing when the device returns to dial mode after entering injection mode.

  Each of the wiper assemblies 870 and 880 cooperates with a different sensing band, each sensing band being formed with a pair of specially shaped conductive bands formed to have different areas engaged by the wiper elements of the wiper assembly. Having a body-resistance strip therein. In particular, the wiper assembly 870 wraps around the core member 890 or cooperates with or functions with the sensing band specified generally at 891. The wiper assembly 880 cooperates with a sensing band, shown in the cross-sectional view of FIG. 24 and generally referenced 897, that wraps inside the core member 890. Each sensing band 891 and 897 is rotationally and axially secured using a core member 890 and, thus, indirectly rotationally secured to the device housing. Sensing bands 891 and 897 are attached to core member 890 such that sensing bands 680 and 700 fit within, around, and through core member 650.

  With further reference to the flat configuration of the sensing band shown in FIG. 25, the structure and design of the sensing band 891 will be further described. This description of sensing band 891 applies to similarly configured sensing band 897, but sensing band 891 cooperates with wiper assembly 870 to sense barrel position and sensing band 897 cooperates with wiper assembly 880. To detect the position of the drive sleeve. The sensing band 891 holds the sensing strip pair and is shown to include a sensing portion 892 that when installed is in the form of a cylindrical sleeve. Connector foot 899 is used to make an electrical connection between the sensing strip pair in sensing portion 892 and the device controller.

  The effective shape of the pair of conductor-resistor strips extending into the sensing portion 892, and thus the effective sensing area of the sensing portion 892, is shown in dashed lines in FIG. The sensing area includes a main path 893 and a secondary path 902, which are different areas of the same electrical strip so as to be electrically integrated, thereby irrespective of whether it was created by the main path 893 or the secondary path 902. Instead, the controller can receive a single electrical output from the sensing band 891. Main path 893 extends continuously between corner ends 894 and 896. The main path 893 is axially positioned within the device to be operatively aligned axially to contact the wiper element of the wiper 872. As barrel 850 rotates during use, main path 893 never contacts wiper 874. When the sensing band 891 is placed around the core member 890, the main path 893 substantially completely surrounds the core member. The only perimeter that is not ringed is a small angular area or gap 895 in the perimeter between opposing corner ends 894 and 896. The device controller can determine where the wiper element of the wiper 872 operatively contacts the main path 893 along the angular length of the main path 893 and senses the position of the barrel 860 relative to the core member 890 to determine the device Allows the dose set for the device to be identified by the controller.

  The secondary path 902 extends continuously between the corner ends 904 and 906 and projects directly forward from the main path 893 in the axial direction. The secondary path 902 is axially positioned within the device to operatively align axially to contact the wiper element of the wiper 874 and never contacts the wiper 872. Secondary path 902 has an angular length extending between ends 904 and 906 that covers the length of angular gap 895. Secondary path 902 is positioned along the angular length of main path 893 to account for the angular spacing between wiper elements of wipers 872 and 874 so as to achieve a design in which wiper 874 is always engaged with secondary path 902. The wiper 874 is within the angular gap 895 and is not in operative contact with the main path 893. The secondary path 902 is shown as being positioned midway along the angular length of the main path 893 for the wipers 872 and 874 to start 180 degrees apart about the core member 890, although an alternate implementation is shown. In an embodiment, the wipers can be positioned differently to account for different angular spacings. Alternatively, the secondary path 902 may be formed as a separate second sensing band (not shown), located axially adjacent to the main path 893 of the first sensing band. A separate second sensing band is in contact with and associated with wiper 874, while a first sensing band having main path 832 is in contact with and associated with wiper 872.

  The device controller recognizes the barrel rotation position from a single electrical signal received from the sensing band 891. During most barrel rotations, the magnitude of the electrical signal to the device controller reflects where the wiper 872 engages the main path 893 while the wiper 874 does not engage the secondary path 902. When the wiper 872 enters the rotation gap 895 and is no longer engaged with the main path 893, the wiper 874 is engaged simultaneously with the secondary path 902, and the signal is instantaneously located where the signal was shorted by the immediately preceding wiper element 872. Are significantly different. This modified signal value, as well as the value of that signal that further changes as the wiper 874 moves along the angular length of the secondary path 902, re-engages the wiper 872 with the main path 893 while the wiper 874 Until is out of the secondary path 902, the controller can recognize the barrel rotation position.

  It will be appreciated that the secondary path 902 may have an angular length that is not the same angular length as the gap 895, but is greater than the angular length of the gap 895, for example, several degrees. In such a design, for every possible rotational or angular position of the associated sensing member, there will always be at least one wiper in contact with the sensing band, but the wiper 874 will be several degrees of the secondary path 902 There is also a particular rotational position of the sensing member where the wiper 872 also engages the main path 893 while engaging with the length of the sensing member. At such a particular rotational position, depending on the electrical configuration of the sensor, the output signal generated by sensing band 891 is the average of the signals transmitted by wipers 874 and 872 in contact with their respective paths. Thus, it will be appreciated that a single signal transmitted by the sensing band 891 to the device controller can introduce uncertainty into the controller. This uncertainty causes the wiper to be active over a sufficiently large angular distance so that the controller provides the controller with a continuous characteristic signal from the sensing band 891 to allow the controller to resolve the known reference position. This can be solved by an initialization operation including rotating.

  Although the present invention has been shown and described as having a preferred design, the present invention may be varied within the spirit and scope of the present disclosure. For example, the module 400 can sense a dose set when adapted to work with a device portion having the appropriate portion to experience relative rotation during dose setting. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such deviations from the present disclosure as are within known or customary practice in the art to which this invention pertains.

  While the invention has been illustrated and described in detail in the drawings and foregoing, it is to be understood that these are exemplary and not limiting in nature. All changes, equivalents, and modifications that fall within the spirit of the invention as defined by the claims contained herein are desired to be protected.

  Various aspects are described in this disclosure, including but not limited to the following aspects.

  1. A drug delivery device, comprising: a first member; and a first member about an axis of rotation in proportion to at least one of a dose set and a dose delivered by operation of the drug delivery device. A second member rotatable with respect to the first member, a radially protruding wiper coupled to the first member, and an electrically operable sensing band coupled to the second member. Are arranged in a curved configuration and are radially disposed with respect to and in contact with the wiper, and during relative rotation between the first and second members, the sensing band moves relative to the first and second members. An electrically operable sensing band operable to generate an output associated with a relative angular position of the wiper along an operating angular length of the sensing band indicating a rotational position, and an output operable based on the output generated by the sensing band. Zu A controller electrically coupled to the sensing band to determine at least one of the dose set and the dose delivered by operation of the drug delivery device. .

  2. A radially protruding second wiper coupled to the first member; and an electrically operable second sensing band coupled to the second member, wherein the second sensing band is Arranged in a curved configuration and radially disposed with respect to and in contact with the second wiper, wherein a second sensing band is disposed axially with respect to the sensing band and between the first and second members. During the relative rotation at the second sensing band is associated with the relative angular position of the second wiper along the operating angular length of the second sensing band indicating the relative rotational position of the first and second members. The controller is operable to generate an output based on the output generated by the second sensing band. Determine at least one of Because the second sensing bands and are electrically coupled, the drug delivery device according to embodiment 1.

  3. Aspect 3. The drug delivery device of aspect 2, wherein the second wiper extends further axially than the first wiper.

  4. 5. The drug delivery device according to aspect 4, wherein the sensing band is configured to house the first and second wipers.

  5. 5. The drug delivery device according to any one of aspects 2-4, wherein the second wiper is circumferentially disposed at substantially 180 degrees with respect to the first wiper.

  6. A drug delivery device, wherein the first member and a second member rotatable relative to the first member about an axis of rotation in proportion to an amount of administration set by operation of the drug delivery device; A third member, a fourth member rotatable with respect to the third member about an axis of rotation in proportion to an amount of dose delivered by operation of the drug delivery device, and a fourth member coupled to the first member. A radially protruding first wiper, a radially protruding second wiper coupled to a third member, and an electrically operable first sensing band coupled to the second member. And a second electrically operable sensing band coupled to the fourth member, wherein each of the first and second sensing bands are arranged in a curved configuration and include a first wiper and a second Radial in each of the wipers and in contact relation And wherein during the relative rotation between the first and second members, and during the relative rotation between the third and fourth members, the first and second sensing bands, respectively, An output associated with the relative angular position of the corresponding first and second wipers along respective operating angular lengths of the first and second sensing bands indicating the relative rotational position of the member and the third and fourth members. An electrically operable second sensing band operable to generate a dose and an administration set by operation of the drug delivery device based on the output generated by the first and second sensing bands. And a controller electrically coupled to each of the first and second sensing bands to determine an amount of the drug delivered and an amount of the delivered dose.

  7. The drug delivery device according to aspect 6, wherein the second member and the fourth member are integrally formed as a single core member.

  8. The drug delivery device according to aspect 6 or 7, further comprising a pair of first wipers coupled to the first member and a pair of second wipers coupled to the third member.

  9. A pair of electrically operable first sensing bands coupled to the second member and associated with the pair of first wipers; and a pair of second wipers coupled to the fourth member and Aspect 9. The drug delivery device of aspect 8, further comprising an associated pair of electrically operable second sensing bands.

  10. A drug delivery device, comprising: a first member of the drug delivery device; and a first member proportional to at least one of an amount of administration set by operation of the drug delivery device and an amount of delivered dose. A second member of the drug delivery device rotatable with respect to the second member, wherein the first and second members are relatively rotatable about an axially extending rotation axis; A sensing system operable to detect a relative rotational position of the first and second members and to generate an output correlated to such relative rotational position, the sensing system being rotatably coupled to the first member; A radially protruding wiper, a sensing band rotatably coupled to the second member, and connected to a power source, wherein the sensing band is arranged in a curved shape about a rotation axis, and an operating angle. Length and the sensing band The sensing member is disposed radially inward or outward of the wiper such that the sensing band is in physical contact with the wiper when the second member rotates relative to the first member so as to physically contact the wiper. A sensing band having electrical properties that correlate with locations where the sensing band is radially operatively engaged along the angular length; and A drug delivery device, comprising: a controller electrically connected to the sensing system to identify at least one of the dose set by the operation and the dose delivered.

  11. At least one of the wiper and the sensing band may be radially resilient to help maintain physical contact between the wiper and the sensing band as the second member rotates relative to the first member. 11. A drug delivery device according to aspect 10.

  12. At least one of the wiper and the sensing band are each rotatable to help maintain physical contact between the wiper and the sensing band as the second member rotates relative to the first member. 12. A drug delivery device according to aspect 10 or 11, wherein the drug delivery device is radially biased relative to the first and second members being coupled.

  13. Aspect 13. The drug delivery device according to any one of aspects 10-12, wherein the sensing band is disposed radially outward of the wiper.

  14． 14. The drug delivery device according to any one of aspects 10-13, wherein the second member comprises a housing of the drug delivery device.

  15. 15. The drug delivery device according to aspect 14, wherein the sensing band is mounted directly on the inner peripheral surface of the housing.

  16. 15. The drug delivery device according to aspect 14, wherein the sensing band is disposed on a component that is at least rotatably fixedly mounted to the housing.

  17． 17. The drug delivery device according to any one of aspects 10-16, wherein the operating angle length extends only partially around the circumference of the second member.

  18. Aspect 18. The drug delivery device of aspect 17, wherein the operating angle length extends from at least 345 degrees to less than 360 degrees around the inner circumference of the second member.

  19. A sensing system including a second wiper rotatably coupled to the first member and protruding in a radial direction, and a second sensing band rotatably coupled to the second member and the power source; A second sensing band is arranged in a curved shape about the axis of rotation and has an operating angle length, wherein the second sensing band is configured to rotate when the second member rotates relative to the first member. A second wiper is disposed radially inward or outward of the second wiper so as to make physical contact with the second wiper, and the second sensing band is moved along the operating angle length by physical contact with the second wiper. 19. The drug delivery device according to any one of aspects 10-18, wherein the device has electrical properties that correlate with where the second sensing band is radially engaged.

  20. 20. A drug delivery device according to aspect 19, wherein the operating angular lengths of the sensing band and the second sensing band are axially spaced, each extending only partially around the circumference of the second member.

  21. 21. The drug delivery device according to aspect 20, wherein the wiper and the second wiper include different areas of a single wiper body.

  22. The sensing system and the controller are part of a reusable dose delivery detection module, and the reusable dose delivery detection module is later attached to a corresponding member of another drug delivery device for use therewith. 22. The drug delivery device according to any one of aspects 10-21, wherein the drug delivery device is removable from the first member and the second member for mounting.

  23. A sensing band is disposed radially outside the wiper, a first electrical strip includes a resistive strip, a second electrical strip includes a conductive strip, and the conductive strip is disposed radially inward of the resistive strip. 23. The drug delivery device according to any one of aspects 10-22, wherein the conductor strip is bendable radially outward to make electrical contact with the resistive strip at an angular position engaged by the wiper.

  24. 24. The medicament according to any one of aspects 10-23, wherein the second member includes a core member having an inner surface defining a hole in which the first member rotates, the sensing band being laminated to the inner surface. Delivery device.

  25. An aspect wherein the core member includes an outer surface and an opening extending between the inner and outer surfaces, and the sensing band includes a connector leg having an electrical lead that passes through the opening and wraps around the outer surface. 25. The drug delivery device according to 24.

  26. The sensing band is a first sensing band, the wiper is a first wiper, and the rotation axis is proportional to at least one of the dose set and the dose delivered by operation of the drug delivery device. A third member of the drug delivery device rotatable about the core member with respect to the third member, wherein the sensing system is rotatably coupled to the third member and projects radially inward or outward. Further comprising a second wiper and a second sensing band rotatably coupled to the core member, wherein the second sensing band is configured to rotate when the third member rotates relative to the core member. Wrapping along the surface of the core member to operatively contact the wiper, wherein the second sensing band has an electrical characteristic that correlates to where the second sensing band is operatively engaged by the second wiper. Having, Drug delivery device as claimed in like 24.

  27. 27. The drug delivery device according to aspect 26, wherein the first and second sensing bands sandwich the core member directly therebetween.

  28. Aspect 27. The drug delivery device according to aspect 26, wherein the second sensing band is positioned at a radial position between the first sensing band and the second wiper.

  29. Aspect 24. The drug delivery device of aspect 24, wherein the core member is separately formed and rotatably secured to a housing of the drug delivery device.

  30. A medicament delivery device for delivering medicament from a cartridge having a barrel holding the medicament between a movable plunger and an outlet, the medicament delivery device holding a main housing and a cartridge extending from the main housing. A drive member including a cartridge housing and a front end for engaging the movable plunger, the drive member having a length extending axially within the main housing, and through the outlet. A dose delivery mechanism for controlling the advancement of the drive member axially forward within the main housing to move the movable plunger to deliver the medicament, wherein the dose delivery mechanism comprises a medicament delivery device. First rotatable relative to the main housing in proportion to at least one of the dose set and the dose delivered by the operation of A dose delivery mechanism including a member, wherein the first member is rotatable relative to the main housing about an axially extending axis of rotation; and a relative rotation of the first member and the main housing. A sensing system operable to detect position and generate an output correlated to such relative rotational position, the system comprising a first wiper coupled to the first member and projecting in a radial direction; A first sensing band coupled to the housing, wherein the first sensing band is arranged in a curved shape about an axis of rotation, has a first operating angle length, and wherein the first sensing band comprises a first sensing band. A first sensing band is disposed radially inwardly or outwardly of the first wiper such that the first member is in physical contact with the first wiper while rotating with respect to the main housing, and wherein the first sensing band includes a first sensing band. Physical contact with the first wiper A first sensing band having electrical properties that correlate with where the first sensing band is radially operatively engaged along the angular length; and A controller in electrical communication with the sensing system to identify at least one of the dose set and the dose delivered based on operation of the drug delivery device based on the drug delivery device. .

  31. Aspect 30. The drug delivery device of aspect 30, wherein the first sensing band is rotatably coupled to the main housing via the core member, and the core member is separately formed and rotatably secured to the main housing.

  32. A first sensing band is disposed on the core member, wherein the core member is axially movable within the main housing, and wherein the first wiper is first moved such that the first wiper moves axially with the first member. Wherein the first member is axially movable within the main housing during operation of the drug delivery device, and wherein the core member and the first sensing band comprise a first wiper and a first sensing band. 32. The drug delivery device according to aspect 31, wherein the drug delivery device is forced to move axially with the first member to maintain alignment of the one sensing band.

  33. The first sensing band is rotatably coupled to the main housing via a core member having an inner surface defining an aperture in which the first member is rotatably disposed, wherein the first sensing band includes an inner surface. Aspect 30. The drug delivery device of aspect 30, wherein the device is wrapped along and disposed radially outward of the first wiper.

  34. A second member of the drug delivery device that is rotatable relative to the core member about an axis of rotation in proportion to the other of the dose set by the operation of the drug delivery device and the delivered dose. Wherein the sensing system further comprises a second wiper rotatably coupled to the second member and projecting radially inward, and the second member rotatably coupled to the main housing via the core member. A second sensing band coupled and connected to a power source, wherein the second sensing band is arranged in a curved shape about an axis of rotation and has a second operating angle length; A sensing band wraps around the outer surface of the core member and is radially inward of the second wiper to make physical contact with the second wiper as the second member rotates relative to the main housing. A second sensing van positioned Is a third electrical strip that makes electrical contact along a second operating angle length when the second sensing band is operatively engaged in a radial direction by physical contact with a second wiper. And a fourth electrical strip, wherein the third electrical strip and the fourth electrical strip are radially spaced apart, and physical contact with the second wiper causes the second sensing band to move radially operatively. If not engaged, the second sensing band is disengaged from electrical contact along the second operating angle, and the second sensing band is moved along the second operating angle by physical contact with the second wiper. Aspect 33. A drug delivery device according to aspect 33, wherein the second sensing band has an electrical property that correlates with a location where the second sensing band is radially operatively engaged.

  35. The first sensing band makes electrical contact along a first operating angle length when the first sensing band is operatively engaged in a radial direction by physical contact with the first wiper. A first electrical strip and a second electrical strip, wherein the first electrical strip and the second electrical strip radially operatively engage a first sensing band in physical contact with a first wiper. Otherwise, radially spaced apart from electrical contact along the first operating angle length, the first and second sensing bands directly sandwich the core member therebetween. A drug delivery device as described.

  36. The first and second electrical strips include a main portion and a secondary portion, the secondary portion extending directly axially from the main portion, and a first wiper engaging the main portion but the secondary portion. Aspect 35. The drug delivery device of aspect 35, wherein the sensing system includes a second wiper in an axial position that does not engage the portion and the sensing system is in an axial position that engages the secondary portion but does not engage the main portion.

  37. The drug delivery device according to any one of aspects 34-36, wherein the first wiper and the second wiper are angularly spaced about an axis of rotation.

  38. Aspect 38. The drug delivery device according to any one of aspects 34-37, wherein the second wiper extends further axially than the first wiper.

  39. Aspect 39. The drug delivery device according to any one of aspects 34-38, wherein the second wiper is disposed at substantially 180 degrees circumferentially with respect to the first wiper.

  40. Aspect 30 further includes: a pair of first wipers coupled to the first member; and a pair of first sensing bands coupled to the main housing in physical contact with the respective first wipers. 40. The drug delivery device according to any one of -39.

Claims (40)

A drug delivery device, comprising:
A first member, and rotatable with respect to the first member about an axis of rotation in proportion to at least one of the dose set and the dose delivered by operation of the drug delivery device; A second member,
A radially protruding wiper coupled to the first member;
An electrically operable sensing band coupled to the second member, wherein the sensing band is arranged in a curved shape, and is radially disposed in contact with and in contact with the wiper; And during relative rotation between the first and second members, the sensing band is associated with a relative angular position of the wiper along an operating angular length of the sensing band indicating a relative rotational position of the first and second members. An electrically operable sensing band operable to produce a controlled output;
Detecting the amount of the dose set by operation of the drug delivery device and / or the amount of the delivered dose based on the output generated by the sensing band; A drug delivery device comprising: a controller electrically coupled to the band.   A radially protruding second wiper coupled to the first member, and an electrically operable second sensing band coupled to the second member; A sensing band arranged in a curved shape and radially disposed with respect to and in contact with the second wiper, wherein the second sensing band is axially disposed with respect to the sensing band; During relative rotation between the first and second members, the second sensing band moves along an operating angle length of the second sensing band indicating a relative rotational position of the first and second members. Operable to generate an output associated with a relative angular position of a second wiper, wherein the controller is operable to generate the output of the dosing based on the output generated by the second sensing band. Amount and delivery of the drug To determine at least one of said amount of delivered the administered by vice operating, the second sensing bands and are electrically coupled, the drug delivery device according to claim 1.   4. The drug delivery device of claim 3, wherein the second wiper extends further axially than the first wiper.   The drug delivery device according to claim 4, wherein the sensing band is configured to house the first and second wipers.   The drug delivery device according to any one of claims 2 to 4, wherein the second wiper is circumferentially disposed at substantially 180 degrees with respect to the first wiper. A drug delivery device, comprising:
A first member, and a second member rotatable with respect to the first member about an axis of rotation in proportion to an amount of administration set by operation of the drug delivery device;
A third member, and a fourth member rotatable with respect to the third member about an axis of rotation in proportion to an amount of dose delivered by operation of the drug delivery device;
A radially protruding first wiper coupled to the first member;
A radially protruding second wiper coupled to the third member;
An electrically operable first sensing band coupled to the second member;
An electrically operable second sensing band coupled to the fourth member, wherein each of the first and second sensing bands are arranged in a curved shape, and wherein the first wiper and the second Two wipers are disposed radially with respect to each other and in contact relationship, and during relative rotation between the first and second members, and during relative rotation between the third and fourth members, Operating angle length of each of the first and second sensing bands, wherein each of the first and second sensing bands indicates a relative rotational position of the first and second members and the third and fourth members. An electrically operable second sensing band operable to generate an output associated with a relative angular position of the corresponding first and second wipers along
Determining, based on the output generated by the first and second sensing bands, the amount of the dose set by operation of the drug delivery device and the amount of the delivered dose; A controller electrically coupled to each of the first and second sensing bands.   The drug delivery device according to claim 6, wherein the second member and the fourth member are integrally formed as a single core member.   The drug delivery device according to claim 6, further comprising a pair of first wipers coupled to the first member and a pair of second wipers coupled to the third member.   A pair of electrically operable first sensing bands coupled to the second member and associated with the pair of first wipers; and a pair of fourth sensing members coupled to the fourth member. The drug delivery device of claim 8, further comprising: a pair of electrically operable second sensing bands associated with the two wipers. A drug delivery device, comprising:
A first member of the drug delivery device;
A second member of the drug delivery device that is rotatable relative to the first member in proportion to at least one of a dose set by the operation of the drug delivery device and a delivered dose. A second member, wherein the first and second members are relatively rotatable about an axis of rotation extending in an axial direction;
A sensing system operable to detect a relative rotational position of the first and second members and to generate an output correlated to such relative rotational position;
A wiper rotatably coupled to the first member and projecting in a radial direction;
A sensing band rotatably coupled to the second member and connected to a power source, wherein the sensing band is arranged in a curved shape around the rotation axis, and has an operating angle length; A sensing band disposed radially inward or outward of the wiper such that the sensing member is in physical contact with the wiper when the second member rotates relative to the first member, wherein the sensing band comprises: A sensing band having electrical properties that correlate with where the sensing band is operatively engaged in the radial direction along the operating angle length by physical contact with the wiper. ,
An electrical connection with the sensing system to identify at least one of the amount of the dose and the amount of the delivered dose set by operation of the drug delivery device based on an output of the sensing system; And a controller connected to the drug delivery device.   At least one of the wiper and the sensing band is configured to assist in maintaining physical contact between the wiper and the sensing band as the second member rotates relative to the first member. The drug delivery device of claim 10, wherein the device is radially elastic.   At least one of the wiper and the sensing band is configured to assist in maintaining physical contact between the wiper and the sensing band as the second member rotates relative to the first member. The drug delivery device of claim 10, wherein the device is radially biased against the first and second members, each of which is rotatably coupled.   The drug delivery device according to claim 10, wherein the sensing band is located radially outward of the wiper.   14. The drug delivery device according to claim 13, wherein the second member comprises a housing for the drug delivery device.   15. The drug delivery device according to claim 14, wherein the sensing band is directly attached to an inner peripheral surface of the housing.   15. The drug delivery device of claim 14, wherein the sensing band is disposed on a component that is at least rotatably fixedly mounted to the housing.   The drug delivery device of claim 10, wherein the operating angle length extends only partially around a periphery of the second member.   20. The drug delivery device of claim 17, wherein the operating angle length extends from at least 345 degrees to less than 360 degrees around an inner circumference of the second member.   A second wiper rotatably coupled to the first member and the radially protruding second wiper; a second sensing band rotatably coupled to the second member and the power source; And wherein the second sensing band is arranged in a curved shape around the rotation axis and has an operating angle length, and the second member is formed by the second member being the first member. The second sensing band is disposed inside or outside the radial direction of the second wiper so as to make physical contact with the second wiper when rotating with respect to the member of the second wiper. 11. The drug delivery device of claim 10, wherein the physical contact with the wiper has electrical properties that correlate with the location where the second sensing band is radially engaged along the operating angle length. .   20. The method of claim 19, wherein the operating angle lengths of the sensing band and the second sensing band are axially spaced, each extending only partially around the circumference of the second member. Drug delivery device.   21. The drug delivery device of claim 20, wherein the wiper and the second wiper include different areas of a single wiper body.   The sensing system and the controller are part of a reusable dose delivery detection module, wherein the reusable dose delivery detection module is a corresponding member of another drug delivery device for use therewith The drug delivery device of claim 10, wherein the device is removable from the first member and the second member for later mounting on the device.   The sensing band is located radially outward of the wiper, the first electrical strip comprises a resistive strip, the second electrical strip comprises a conductive strip, and the conductive strip comprises a conductive strip. The method according to claim 10, wherein the conductor strip is radially inward and bendable radially outward to make electrical contact with the resistive strip at an angular position engaged by the wiper. Drug delivery device.   The drug delivery device of claim 10, wherein the second member comprises a core member having an inner surface defining a hole in which the first member rotates, and wherein the sensing band is laminated to the inner surface. .   A connector wherein the core member includes an outer surface and an opening extending between the inner surface and the outer surface, the sensing band having an electrical lead passing through the opening and winding along the outer surface. 25. The drug delivery device according to claim 24, comprising a leg.   The sensing band is a first sensing band, and the wiper is a first wiper, and is proportional to at least one of a dose set and a dose delivered by operation of the drug delivery device. A third member of the drug delivery device rotatable about the axis of rotation with respect to the core member, wherein the sensing system is rotatably coupled to the third member, and wherein A second wiper protruding inward or outward, and a second sensing band rotatably coupled to the core member, wherein the second sensing band is such that the third member is the third member. Wrapping around the surface of the core member so as to operatively contact the second wiper when rotating with respect to the core member, wherein the second sensing band is such that the second sensing band is Drug delivery device of the has an electrical characteristic that correlates with operatively engaged by location by a wiper, claim 24.   27. The drug delivery device of claim 26, wherein the first and second sensing bands sandwich the core member directly therebetween.   27. The drug delivery device of claim 26, wherein the second sensing band is located at the radial position between the first sensing band and the second wiper.   25. The drug delivery device of claim 24, wherein the core member is separately formed and rotatably secured to a housing of the drug delivery device. A drug delivery device for delivering a drug from a cartridge having a barrel holding the drug between a movable plunger and an outlet, the drug delivery device comprising:
A main housing,
A cartridge housing for holding the cartridge extending from the main housing;
A drive member including a front end for engaging the movable plunger, the drive member having a length extending axially within the main housing; and
A dose delivery mechanism for controlling advancement of the drive member axially forward within the main housing to move the movable plunger to deliver a medicament through the outlet; A volume delivery mechanism including a first member rotatable relative to the main housing in proportion to one of a volume of administration set by operation of the drug delivery device and a volume of volume delivered; A dose delivery mechanism, wherein a first member is rotatable relative to the main housing about the axis of rotation extending in the axial direction;
A sensing system operable to detect a relative rotational position of the first member and the main housing and to generate an output correlated to such relative rotational position;
A first wiper coupled to the first member and projecting in a radial direction;
A first sensing band coupled to the main housing, wherein the first sensing band is arranged in a curved shape about the axis of rotation, has a first operating angle length, and has a first sensing band. A band disposed radially inward or outward of the first wiper such that the band is in physical contact with the first wiper while the first member is rotating relative to the main housing; Where the first sensing band is operatively engaged in the radial direction along the first operating angle length by physical contact with the first wiper; A sensing system, comprising: a first sensing band having correlated electrical properties;
An electrical connection with the sensing system to identify at least one of the amount of the dose and the amount of the delivered dose set by operation of the drug delivery device based on an output of the sensing system; And a controller in communication with the drug delivery device.   31. The first sensing band is rotatably coupled to the main housing via a core member, wherein the core member is separately formed and rotatably secured to the main housing. Drug delivery device.   The first sensing band is disposed on the core member, the core member is axially movable within the main housing, and the first wiper is axially movable with the first member. The first member is fixedly coupled to the first member for movement, the first member being axially movable within the main housing during operation of the medicament delivery device; 32. The sensor of claim 31, wherein one sensing band is forced to move axially with the first member to maintain alignment of the first wiper with the first sensing band. Drug delivery device.   The first sensing band is rotatably coupled to the main housing via a core member having an inner surface defining a hole in which the first member is rotatably disposed, and wherein the first sensing band is rotatably coupled to the main housing. 31. The drug delivery device of claim 30, wherein a band wraps around the inner surface and is disposed radially outward of the first wiper.   The drug delivery device being rotatable relative to the core member about the axis of rotation in proportion to the other of the amount of administration set by operation of the drug delivery device and the amount of delivered administration. The second member of claim 2, wherein the sensing system further comprises a second wiper rotatably coupled to the second member and protruding inwardly in the radial direction, and the core A second sensing band rotatably coupled to the main housing via a member and connected to the power source, wherein the second sensing band is arranged in a curved shape about the rotation axis; And a second operating angle length, wherein the second sensing band wraps around the outer surface of the core member and the second member rotates when the second member rotates relative to the main housing. Wiper The second sensing band is disposed radially inward of the second wiper so as to make physical contact, and the second sensing band is moved in the radial direction by physical contact with the second wiper. A third electrical strip and a fourth electrical strip in electrical contact along the second operating angle length operatively engaged with the third electrical strip and the fourth electrical strip. Strips are spaced apart in the radial direction and along the second operating angle length where the second sensing band is not operatively engaged in the radial direction by physical contact with the second wiper. Deviating from electrical contact, the second sensing band is operatively moved in the radial direction along the second operating angle length by physical contact with the second wiper. Where to be engaged It has an electrical characteristic that correlates the drug delivery device according to claim 33.   The first sensing band is electrically connected along the first operating angle length with which the first sensing band is operatively engaged in the radial direction by physical contact with the first wiper. A first electrical strip and a second electrical strip contacting the first and second electrical strips, wherein the first and second electrical strips are configured such that the first sensing band is in physical contact with the first wiper. The radially spaced apart and out of electrical contact along the first operating angle length that is not operatively engaged in the radial direction, the first and second sensing bands being between them. 35. The drug delivery device according to claim 34, wherein said core member is directly sandwiched between said core members.   The first and second electrical strips include a main portion and a secondary portion, wherein the secondary portion extends directly from the main portion in the axial direction, and wherein the first wiper is connected to the main portion. The sensing system includes a second wiper in an axial position that engages but does not engage the secondary portion, and wherein the sensing system is in an axial position that engages the secondary portion but does not engage the main portion. 36. The drug delivery device of claim 35.   35. The drug delivery device of claim 34, wherein the first wiper and the second wiper are angularly spaced about the axis of rotation.   35. The drug delivery device of claim 34, wherein the second wiper extends further axially than the first wiper.   39. The drug delivery device of claim 38, wherein the second wiper is disposed substantially 180 degrees circumferentially with respect to the first wiper.   Further comprising: a pair of first wipers coupled to the first member; and a pair of first sensing bands coupled to the main housing in physical contact with the respective first wipers. A drug delivery device according to claim 30.

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